Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

STUDY: SSRIS MAY INCREASE SUICIDE RISK IN SENIORS

Older patients taking selective serotonin reuptake
inhibitors, or SSRIs -- a class of antidepressants that includes Prozac,
Paxil and Zoloft -- may be more likely to have intense suicidal thoughts
or commit suicide, according to data published in the American Journal of
Psychiatry. The study, conducted by researchers at the Institute for Clinical
Evaluative Sciences in Toronto, showed that the suicide rate among seniors taking
SSRIs was nearly five times higher than among those who were treated with other
forms of antidepressants.

The study was conducted using patient prescription data, physician billing
claims, hospitalization data and coroner's records for Ontario residents 66
and older between 1992 and 2000. There were about 1.2 million seniors whose
information was examined, including 1,329 suicide cases. Among seniors who had
committed suicide, more than two-thirds (907 people) had received no treatment.
In the nine-year period, 73 patients taking SSRIs committed suicide, as did
349 patients taking other antidepressants.

David Juurlink, the study's lead author, noted, however, that it is difficult
to distinguish the role of depression itself from the possible effects of the
medication, In patients with major depression, he said, the "hazards of
undertreatment almost certainly outweigh the risks of therapy."

In Canada, he added, there are approximately 16 million SSRI prescriptions
issued annually, at a total cost of more than $1 billion.